Senate Activity Prior to Recess [Summary Memo]

2017-08-10 | , Association for Clinical and Translational Science

August 4, 2017

MEMORANDUM

TO:Coalition for Clinical and Translational Science 

FR:Dale Dirks and Dane Christiansen 

RE:Senate Health Legislative Action Prior to Recess

Here is a brief update on action the Senate took yesterday before leaving for the August recess:

•The United States Senate confirmed Indiana Health Commissioner Jerome Adams, M.D. as our nation’s 20th Surgeon General. Dr. Adams is highly respected in the public health community.  

•The Senate passed and sent to the President for his signature, the Food and Drug Administration Reauthorization Act of 2017 (FDARA), which reauthorizes FDA user fee programs for five years. The current user fee agreement was set to expire at the end of September. The bill includes the following:

o  Prescription Drug User Fees are extended and revisions are made to FDA user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.
o  Medical Device User Fees are extended and some revisions are made to FDA user fees for medical devices. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill revises the types of medical devices that the FDA may accredit third parties to review.
o  Generic Drug User Fees are extended and some revisions are made to FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.
o  Biosimilar User Fees are extended and some revisions are made to user fees for biosimilars. User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. 
o  Critical Path Public-Private Partnerships are extended and will support the development of medical products for rare conditions.
o  As part of the reauthorization agreement, FDA will support the following activities:

  • Conduct public workshops to gather input into topics related to the use of real-world evidence for regulatory decision making.
  • Initiate appropriate activities (e.g., pilot studies or methodology development projects) aimed at addressing key outstanding concerns and considerations in the use of real-world evidence for regulatory decision making.
  • Publish draft guidance on how real-world evidence can contribute to the assessment of safety and effectiveness in regulatory submissions.
  • Focus on approaches and methods to bridge from the initial patient-focused drug development meetings, like those piloted under PDUFA V, to fit-for-purpose tools to collect meaningful patient and caregiver input for use in regulatory decision making.
  • Issue final guidances on several outstanding issues that need clarification, including “interchangeability”.

•The Senate passed The Trickett Wendler Right to Try Act (S. 204). This legislation would make it easier for terminally ill patients to access drugs that have not been approved by the federal government. The Right to Try bill would prohibit the government from denying such patients access to experimental drugs that are still being reviewed by FDA and have completed a preliminary trial (demonstrating safety). The FDA would be barred from overruling the 37 states that already have “right-to-try” laws on the books. The Senate bill has been sent to the House of Representatives for consideration.

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